Phase 2
N=232
Dose-Finding Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
Breast Cancer · Neutropenia
Bottom Line
View on ClinicalTrials.gov: NCT01648322 ↗Enrolled (actual)
232
Serious AEs
2.6%
Results posted
Mar 2018
Primary outcome: Primary: Duration of Moderate Neurtopenia Post First Chemotherapy Administration — 0.6; 0.6; 0.4; 0.3 days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- F-627 (Drug); Neulasta® (pegfilgrastim) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- EVIVE Biotechnology
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Moderate Neurtopenia Post First Chemotherapy Administration |
0.6; 0.6; 0.4; 0.3; 2.1; 2.1 | — |
| SECONDARY Duration in Days of Grade 3 and Grade 4 Neutropenia for All 4 Chemotherapy Cycles. |
0.4; 0.2; 0.2; 0.1; 1.6; 1.6 | — |
| SECONDARY The Incidence Rate of Febrile Neutropenia |
0; 0; 2; 2 | — |
| SECONDARY The Duration in Days of Total Grade 2-4 Neutropenia |
2.1; 2.0; 1.7 | — |
| SECONDARY The Time to ANC Recovery Post Nadir |
2.4; 2.0; 1.9 | — |
| SECONDARY The Incidence Rates of Grade 2, Grade 3, and Grade 4 Neutropenia for All Chemotherapy Cycles |
17; 14; 11; 10; 28; 25 | — |
| SECONDARY The Depth of the ANC Nadir for All Chemotherapy Cycles |
2.09; 2.41; 3.00; 3.05; 0.68; 0.86 | — |
Summary
This is a randomized open label dose finding study to evaluate the efficacy and safety of F-627 on women with Stage I-IV breast cancer receiving chemotherapy treatment.
Eligibility Criteria
Inclusion Criteria
- Show evidence of a signed (personally or by a legally acceptable representative) and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial.
- Females ≥ 18 years of age.
- Diagnosed with Stage I-IV breast cancer.
- Subject is scheduled to undergo 4 cycles of TC or TAC chemotherapy (Taxotere®, doxorubicin and cyclophosphamide, 75, 50 and 600 mg/m2, respectively).
- ECOG Performance status of ≤ 2.
- White Blood Cell count (WBC) ≥ 4.0 × 109/L, hemoglobin ≥ 11.5 g/dL and a platelet count ≥ 150 × 109/L.
- Demonstrate adequate renal, hepatic function (Liver function tests (ALT, AST, alkaline phosphatase and total bilirubin)) should be less than 2.5x upper limits of normal (ULN). Serum creatinine should be less than 1.7x ULN.
- All subjects must agree to use at least one of the following types of contraception: intrauterine device, implantable progesterone device, progesterone intramuscular injection, or oral contraceptive, which has been started at least one month prior to visit one and will continue for the duration of the trial. The contraceptive patch or condom use with spermicide are also acceptable forms of contraception as long as they will be used continually throughout the duration of the trial.
Exclusion Criteria
- Subject is 2.5 upper limit of normal.
- Patients with active infection, or known to be infected with chronic active Hepatitis B within the last 1 year (unless shown at the time of study entry to be Hepatitis B antigen negative), or having any history of Hepatitis C.
- Women who are pregnant or breast-feeding.
- Patients known to be seropositive for HIV, or who have had an AIDS defining illness or a known immunodeficiency disorder.
- Patients with a history of tuberculosis or exposure to tuberculosis. Patients that have received a prior chest X-ray for suspicion of tuberculosis are also excluded unless they have been confirmed to be PPD negative or they had latent tuberculosis that has been previously treated.
- Subjects with Sickle Cell disease
- Subjects with known hypersensitivity to E.coli derived proteins' pegfilgrastim' filgrastim, or any other component of the study drug.
Data sourced from ClinicalTrials.gov (NCT01648322). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.